NCT01829841已完成2 期
A Randomized, Positive-controlled, Double-blind, Multicenter, Phase II Study of Famitinib as First/Second Line Treatment in Patients With Advanced Metastatic Renal Cell Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
- Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
- The purpose of this study is to compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- •First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients)
- •With measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy)
- •Male or female, age ≥18 and ≤75
- •Life expectancy ≥ 3 months
- •Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed
- •Normal major organ function
- •Signed and dated informed consent
排除标准
- •Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
- •Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ
- •Participated in other clinical trials within four weeks
- •A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
- •Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
- •Patients with hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 440ms) and class I heart failure.
- •Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g
- •Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy
- •Previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
- •The preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range
- •With a history of abuse of psychotropic drugs or mental disorders
- •Patients with Hepatitis B or Hepatitis C
- •History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation
研究组 & 干预措施
Famitinib
Experimental
Famitinib 25 mg qd p.o., 6 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
干预措施: Famitinib (Drug)
Sunitinib
Active Comparator
Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
干预措施: Sunitinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: 18 weeks
次要结局
- Quality of Life(42-day cycle visit until disease progress)
- Progress free survival (PFS)(3 years)
- Overall Survival (OS)(3 years)
- Disease Control Rate (DCR)(3 years)
- Number of Participants with Adverse Events as a Measure of Safety(3 years)
研究者
研究点 (1)
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